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FDA advisers: Ortho Evra patch needs clearer label
December 9, 2011 / 9:01 PM / 6 years ago

FDA advisers: Ortho Evra patch needs clearer label

ADELPHI, Maryland (Reuters) - U.S. drug advisers recommended that the label for Johnson and Johnson’s Ortho Evra birth control patch be simplified to better explain the risk of blood clots.

In a 20 to 3 vote with one abstention, advisers to the Food and Drug Administration found that the current label for Ortho Evra inadequately reflects the risks women face by using it. It is the only contraceptive patch sold in the United States.

The panel voted 19 to 5 that the patch’s risks were outweighed by its benefits, such as pregnancy prevention through a once-weekly application.

All commonly used birth control pills increase women’s chances of getting blood clots. The patch, approved in 2001, has been linked to an even higher risk as it contains a much greater amount of hormone estrogen than a pill.

The current label, which has undergone numerous revisions over the past decade, has a boxed warning of a higher risk compared to older birth control pills. But a new FDA study earlier this year again showed that women using the patch were about 60 percent more likely to get dangerous blood clots.

The same group of advisers on Thursday recommended a more detailed description of blood clot risks and studies for a popular new generation of contraceptive pills, such as Bayer AG’s Yaz and Yasmin.

Those pills contain the compound drospirenone, which has been linked to higher risk of venous and arterial thrombotic events, when a blood clot forms in a leg and can travel to the lung to cause stroke or even death. Ortho Evra does not contain that compound.

The FDA usually follows its advisers’ recommendations.

J&J shares closed 1.2 percent higher at $64.53 on the New York Stock Exchange on Friday.

Reporting by Alina Selyukh; editing by Andre Grenon

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